A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer (PROFILE 1001)
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|ClinicalTrials.gov Identifier: NCT00585195|
Recruitment Status : Recruiting
First Posted : January 3, 2008
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer ALK-positive Non-Small Cell Lung Cancer c-Met Dependent Non-Small Cell Lung Cancer ROS Marker Positive Systemic Anaplastic Large-Cell Lymphoma Advanced Malignancies Except Leukemia||Drug: PF-02341066 Drug: Rifampin Drug: Itraconazole||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of Pf-02341066, A C-met/Hgfr Selective Tyrosine Kinase Inhibitor, Administered Orally To Patients With Advanced Cancer|
|Actual Study Start Date :||April 2006|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2023|
Escalating doses of PF-02341066 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 50 mg to 2000 mg/day administered either once or twice a day. A treatment cycle is considered to be 28 days (or 21 days depending on the cohort).
600 mg QD administered from Cycle 1, Day 16 to Cycle 2, Day 1 (14 days of dosing) in combination with PF-02341066.
Multiple Dose Design: 200 mg QD administered from Cycle 1, Day 1 to Cycle 1, Day 16 (16 days) in combination with PF-02341066.
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 2.5 years ]Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
- Area under the Concentration-Time Curve (AUC) [ Time Frame: 2.0 years ]AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
- Maximum tolerated dose (MTD) [ Time Frame: 2.5 years ]
- Percentage of Participants With Objective Response [ Time Frame: 4.0 years ]Percentage of participants with OR based assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
- Area under the Concentration-Time Curve (AUC) for PF-02341066 when co-administered with rifampin [ Time Frame: 2.0 years ]AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
- Area under the Concentration-Time Curve (AUC) for PF-02341066 when co-administered with itraconazole [ Time Frame: 3.0 years ]AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585195
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|